Evaluating a digital health app for Borderline Personality Disorder
Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder: a Randomized Controlled Trial
This study is testing a digital health app to see if it can help adults with Borderline Personality Disorder manage their symptoms better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 470 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Gaia AG Industry-sponsored |
| Locations | 1 site (Hamburg) |
| Trial ID | NCT06601907 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial involves 470 patients diagnosed with Borderline Personality Disorder (BPD) to assess the effectiveness of the unguided digital therapeutic application, alivis. Participants must be aged 18-65, have a confirmed diagnosis of BPD, and meet specific severity and treatment stability criteria. The study aims to provide insights into how digital interventions can support individuals with BPD in managing their symptoms. The trial will exclude individuals with certain comorbidities or acute mental health conditions to ensure a focused evaluation of the app's effectiveness.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a confirmed diagnosis of Borderline Personality Disorder and stable treatment for at least 30 days.
Not a fit: Patients with comorbid substance use disorders, acute mental health crises, or plans to change their treatment in the next six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this digital health application could provide a new, accessible treatment option for patients with Borderline Personality Disorder.
How similar studies have performed: Other studies have shown promise in using digital interventions for mental health conditions, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Diagnosis of BPD * Borderline severity score (cut-off) of ≥ 1.07 on the BSL-23 * Stable treatment (e.g., psychotherapy, medication, no treatment) for at least 30 days at the time of inclusion * Consent to emergency plan for suicidal crises * Consent to participation * Sufficient knowledge of the German language Exclusion Criteria: * Plans to change treatment (e.g., psychotherapy, medication) in the upcoming 6 months after inclusion * Comorbid diagnosis of substance use disorder * Lifetime diagnosis of psychotic disorder like schizophrenia or schizoaffective disorder (except non-transitory paranoid ideas that can be concomitant with BPD and in which the ability to test reality is mostly preserved) * Diagnosis of a physical condition that can cause serious psychiatric symptoms * Acute decompensation of mental health symptoms, e.g. acute manic state or acute suicidality * BMI \< 15 * Current psychiatric day-care or inpatient treatment * Prior use of the digital intervention priovi
Where this trial is running
Hamburg
- Gaia — Hamburg, Germany (Recruiting)
Study contacts
- Principal investigator: Jan Philipp Klein, Prof. Dr. — Universität zu Lübeck, Zentrum für Integrative Psychiatrie
- Study coordinator: Gitta A Jacob, PD Dr.
- Email: gitta.jacob@gaia-group.com
- Phone: +49 40 349930 374
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.